NCT06982092

Using Diaphragm Ultrasonography, Sugammadex Recovers Diaphragmatic Function More Effectively Than Neostigmine.

Study of Effects of Neostigmine Versus Sugammadex in Ultrasonographic Evaluation of Recovery of Diaphragmatic Function After General Anesthesia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The aim of our study is to assess differences in the recovery of muscle function, using diaphragm ultrasonography, after reversal of a rocuronium-induced block, using neostigmine versus sugammadex

Detailed description

Post-operative residual curarization (PORC) remains an essential clinical challenge. The possibility of assessing muscle function and excluding PORC using noninvasive tools in the perioperative period is very attractive. Therefore, we used diaphragm ultrasonography. The diaphragm is a major respiratory muscle, accounting for 60-70% of the respiratory workload. Its dysfunction involves post-operative respiratory failure. Diaphragm ultrasound imaging is a cheap and portable technique that allows assessment of diaphragm thickness, thickening, and excursion at a point in time or over time, in ambulatory patients and in mechanically ventilated patients. Acetylcholinesterase inhibitors can reverse muscle block, but their short half-life may lead to residual curarization in the ward, especially when intermediate or long-acting NMBAs have been administered. Sugammadex is the first selective reversal drug for steroidal NMBAs; it has been shown to give full and rapid recovery of muscle strength, thus minimizing the occurrence of residual curarization. This study was designed to assess differences in the recovery of the diaphragmatic function, using diaphragm ultrasonography, after reversal of a rocuronium-induced block, using neostigmine versus sugammadex. It was conducted to 60 patients of both sexes, scheduled for FESS surgeries who underwent deep neuromuscular block with rocuronium. Cases were aged 18-65 years, ASA physical status ІІ or III. The patients were randomized by computer software randomization and divided into two equal groups; SUG group (n =30 patients) that received 2 mg/kg sugammadex and NEU group (n =30 patients) that received 50 mic/kg and 0.01-0.02 mg/kg atropine. The following parameters were assessed and recorded; diaphragmatic thickening fraction, diaphragmatic excursion, number of patient with baseline diaphragmatic functionat 30min, spirometry volume, post extubation heart rate, respiratory rate, saturation, bronchospasm, nausea and vomiting.

Conditions

• Perioperative Diaphragmatic Function

Interventions

Type	Name	Description
DRUG	sugammadex	: patients will receive the reversal drug according to the group to which they had been randomised. in the Sugammadex Group will receive 2 mg/kg sugammadex.
DRUG	Neostigmine	Patients in the NEO Group will receive 50 mic/kg neostigmine and .01-.02 mg/kg atropine

Timeline

• Start date: 2024-08-26
• Primary completion: 2025-01-15
• Completion: 2025-01-15
• First posted: 2025-05-21
• Last updated: 2025-05-21

Locations

1 site across 1 country: Egypt